FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
126697–126720 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 22, 1990
BERNSCO LUER NEEDLER ADAPTOR
K900629 · GEI
Bernsco Surgical Supply, Inc.
General & Plastic Surgery · 42d
Cleared Mar 21, 1990
OSTEONICS ECSI HIP STEM SERIES
K900836 · JDI
Osteonics Corp.
Orthopedic · 27d
Cleared Mar 20, 1990
EMG NAVIGATOR & EMG TRAVELER
K893130 · IKN
Bio-Logic Systems Corp.
Neurology · 329d
Cleared Mar 20, 1990
SELBY II INSTRUMENTATION
K895296 · KWP
Advanced Spine Fixation
Orthopedic · 207d
Cleared Mar 20, 1990
ERECTION INDUCER DEVICE (EID)
K896060 · LKY
Performance Medical, Inc.
Gastroenterology & Urology · 153d
Cleared Mar 20, 1990
AUTO SUTURE LATCHLESS ABSORBABLE HEMOSTATIC CLIP*
K900122 · FZP
United States Surgical, A Division of...
General & Plastic Surgery · 70d
Cleared Mar 20, 1990
MOTECH TITANIUM SURGICAL MESH
K900138 · EZX
Biedermann Motech GmbH
General & Plastic Surgery · 68d
Cleared Mar 20, 1990
LABELING CHANGE - VIASPAN(TM) (BELZER UW)
K900492 · KDL
The DU Pont Co.
Gastroenterology & Urology · 46d
Cleared Mar 20, 1990
SURGEONS' GLOVES W/HYPOALLERGENICITY CLAIMS
K900985 · KGO
Productes Del Latex, S.A.
General Hospital · 19d
Cleared Mar 20, 1990
MICROTEK'S SURGICAL LAMP HANDLE & COVER
K901154 · FTA
Microbio-Medics, Inc.
General & Plastic Surgery · 7d
Cleared Mar 19, 1990
ADAM (ACOUSTICAL DEVICE FOR ANATOMICAL MONITORING)
K893557 · DQD
Medical Monitors, Inc.
Cardiovascular · 315d
Cleared Mar 19, 1990
LIPIDIRECT LOW DENSITY LIPOPROTEIN CHOLESTEROL TES
K893740 · MRR
Reference Diagnostics, Inc.
Chemistry · 306d
Cleared Mar 19, 1990
KINAMED CERAMIC ATH TOTAL HIP - 28MM BALL
K894904 · LZO
Kinamed, Inc.
Orthopedic · 230d
Cleared Mar 19, 1990
BIOLOG
K895534 · DRT
Micromedical
Cardiovascular · 187d
Cleared Mar 19, 1990
PACEVIEW
K895535 · KRE
Micromedical
Cardiovascular · 187d
Cleared Mar 19, 1990
HTS 820 CARDIAC MONITOR
K896967 · DSI
Life Sensing Instrument Company, Inc.
Cardiovascular · 91d
Cleared Mar 19, 1990
CHEMO-SHIELD
K897105 · FMF
Vision Plastics, Inc.
General Hospital · 88d
Cleared Mar 19, 1990
SYSTEMATE(TM) TOTAL BILIRUBIN CATALOG NO. 654XX
K897176 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 82d
Cleared Mar 19, 1990
OPUS T4 TEST SYSTEM
K897193 · KLI
Pb Diagnostic Systems, Inc.
Toxicology · 80d
Cleared Mar 19, 1990
ADVANCE PRESSURE MONITOR LINE, HIGH PRES., ADMINI.
K897197 · DTL
Advance Medical Designs, Inc.
Cardiovascular · 80d
Cleared Mar 19, 1990
FLEXIGUIDE(TM) CO2 LASER HOLLOW FLEXIBLE FIBER
K900066 · GEX
Luxar Corp.
General & Plastic Surgery · 74d
Cleared Mar 19, 1990
HEMORRHOIDAL LIGATOR WITH SUCTION
K900086 · KDH
Baxter Healthcare Corp
Gastroenterology & Urology · 74d
Cleared Mar 19, 1990
SHARPLAN ND:YAG DISPOSABLE FIBER DELIVERY SYSTEM
K900153 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 67d
Cleared Mar 19, 1990
SKYTRON UNIVERSE SERIES SURGICAL LIGHTS
K900211 · FSY
Skytron, Div. the Kmw Group, Inc.
General & Plastic Surgery · 61d